Bone Anchor 510(k) Guidance Gets Update
Executive Summary
US FDA has revised and expanded its 1996 guidelines on bone-anchor submissions. The revision discusses clinical and nonclinical testing standards for devices used to fasten tissue to bone, as well as other 510(k) concerns.
You may also be interested in...
CDRH Guidance Priorities Include Lab-Developed Tests, Adverse Event Reporting, Third-Party 510(k) Review
FDA's device center issued its annual “A List” and “B List” guidance priorities for fiscal year 2016, spotlighting efforts to address Unique Device Identification direct marking, Medical Device Reporting rules, laboratory-developed tests, 510(k) third-party review, companion diagnostics, and more.
Addition to Quest Alzheimer's Suite Looks For Biomarker P-Tau217
The test is being integrated into Quest’s AD-Detect portfolio for assessing the risk of Alzheimer’s. It is the third p-tau217 test to make news this month, after new breakthrough designations for Quanterix and Roche and Eli Lilly.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.